Status:
RECRUITING
Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)
Lead Sponsor:
Monash University
Conditions:
Myeloma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison...
Detailed Description
This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. ...
Eligibility Criteria
Inclusion
- Aged greater than or equal to 18 years of age
- Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
- Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG\<4g/L (excluding paraprotein)
- Life expectancy \> 12 months
- Able to give informed consent
Exclusion
- 1\. Treating team deems enrolment in the study is not in the best interests of the patient.
Key Trial Info
Start Date :
May 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT07202052
Start Date
May 6 2025
End Date
March 31 2027
Last Update
October 7 2025
Active Locations (3)
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1
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
2
Austin Hospital
Melbourne, Victoria, Australia, 3004
3
Northern Health
Melbourne, Victoria, Australia, 3004